Cefixime for Oral Suspension 100mg/5mL recall
FDA recall D-0274-2024 · initiated Jan 3, 2024
Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension 100mg/5mL in Jan 2024 — an FDA Class II recall (D-0274-2024) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,608 Bottles
Details
- Product
- Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 3, 2024
- FDA report date
- Feb 7, 2024
Frequently asked
- Was Cefixime for Oral Suspension 100mg/5mL recalled?
- Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension 100mg/5mL in Jan 2024 — an FDA Class II recall (D-0274-2024) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cefixime for Oral Suspension 100mg/5mL recalled?
- Per the FDA enforcement record, the reason for recall D-0274-2024 was: Failed Impurities/Degradation Specifications
- Is a recalled Cefixime for Oral Suspension 100mg/5mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cefixime for Oral Suspension 100mg/5mL are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: F304833, Exp 06/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0274-2024.